LOINCActiveObservation

LOINC Code 82350-0: FDA package insert REMS implementation system

82350-0 is a LOINC code used to identify FDA package insert REMS implementation system in laboratory and clinical observation data. You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges. LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component REMS implementation system. It is commonly used with the system or sample type ^FDA package insert.

Reviewed by HealthAssure Clinical TeamUpdated 21 May 2026

What is this code?

LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component REMS implementation system. It is commonly used with the system or sample type ^FDA package insert.

When is it used?

  • Used in lab systems, EHRs, and clinical data exchange.
  • May identify a test, observation, survey item, or clinical document request rather than a diagnosis.
  • Status: ACTIVE
  • Order vs observation: Observation

What it does not mean

  • The code identifies the observation or test, not the actual result.

Key facts

  • FDA package insert REMS implementation system
  • REMS implementation system
  • DOCUMENT.REF; FDA insert; Narrative; REMS implement syst; Report; SPL; Structured Product Labelling

Where you may see this code

You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges.

Common synonyms

FDA package insert REMS implementation systemFDA insert REMS implement systREMS implementation systemDOC.REF-^FDA package insertNar

Frequently asked questions

Code details

Code82350-0
SystemLOINC
Display nameFDA package insert REMS implementation system
DescriptionREMS implementation system
Short nameFDA insert REMS implement syst
ComponentREMS implementation system
Property-
Timing-
System (specimen)^FDA package insert
ScaleNar
ClassDOC.REF
StatusACTIVE
Order/ObservationObservation

Flags

BillableNo
Valid clinical useNo

Source

SourceLOINC
Version2.82
Releasemain
First released2.58
Last changed2.58

Part names

REMS implementation system-^FDA package insertNar

About this content

This page is prepared by HealthAssure's clinical team using official coding standards from LOINC. AI tools assist with drafting explanations, which are then reviewed and verified by healthcare professionals for accuracy. This content is for informational purposes and does not replace professional medical advice. Meet our team.

LOINC Code 82350-0 | HealthAssure